CDDF Multi-Stakeholder Workshop
Enabling Smarter Clinical Trials to optimize patient care
17 November – 18 November 2025, Hybrid Workshop
Recordings
SESSION 1: Clinical trials and real world evidence: what really matters
Session 1 – complete
Enabling Clinical Trials: Taking a proportionate approach – focusing on what really matters – Juan Estevez (AEMPS, ES)
Fireside chat – Hugues Malonne (FAGG-AFMPS, BE)
Turning Data into Decisions: Real-World Evidence in Regulation – Alexandra Pacurariu (EMA, NL)
Session 1 – Panel discussion
SESSION 2: Use of pragmatic elements in clinical trials
Session 2 – complete
Matching trials aims to design decisions: how PRECIS-2 can help, and how PRECIS-3 will be better – Shaun Treweek (University of Aberdeen, UK)
Patient perspective – Gilliosa Spurrier-Bernard (MelanomeFrance, FR)
Designing trials with pragmatic elements to generate high-quality real-world evidence for regulatory decisions – Nafsika Kronidou-Horst (Roche, CH)
Safety data report – ICH E19 – how we streamline – example of pragmatic elements – regulatory component – Peter Mol (University of Groningen, NL)
Session 2 – Panel discussion
SESSION 3: Driving research using health data
Session 3 – complete
EMA article – clinical evidence 2030 – Marianne Lunzer (CTCG, AT)
Unlocking the Power of Real-World Data Across the Full Lifecycle of Cancer Clinical Trials – Ariel Bourla (Johnson & Johnson, U.S)
From Patient Experience to HTA Evidence: The MyLymphoma Model for Real-World Data Generation – Natacha Bolanos (Lymphoma Coalition, ES)
Supporting drug development through new evidence generation approaches – Alison Cave (Medicines and Healthcare products Regulatory Agency, U.K)
Session 3 – Panel discussion
SESSION 4: Wrap-up and panel discussion
Session 4 – complete